SynRx Therapeutics, a precision oncology company focused on DNA damage repair and synthetic lethality, announced that on July 24th, the U.S. Food and Drug Administration (FDA) completed its safety review of the Investigational New Drug (IND) application for SYN818 and has permitted the clinical study to proceed in solid tumors. This milestone marks the first innovative drug from SynRx Therapeutics to enter the clinical development stage. Additionally, on July 23rd, the Center for Drug Evaluation (CDE) of the National Medical Products Administration in China accepted the IND application for SYN818.

Dr. Song Liu, Co-founder and CEO of SynRx Therapeutics, commented: "The IND clearance of SYN818 signifies a new phase in our drug development journey. We are eager to further validate the safety and efficacy of SYN818 through clinical trials, offering new hope to cancer patients."

SYN818 is a novel small molecule inhibitor independently developed by SynRx Therapeutics. It specifically targets DNA polymerase theta (Polθ), effectively inhibiting DNA damage repair in tumor cells and selectively inducing cell death. Preclinical studies have demonstrated that SYN818 efficiently inhibits Polθ protein activity, thereby blocking the MMEJ repair pathway and exhibiting a synthetic lethal effect in the presence of homologous recombination deficiency (HRD). Furthermore, SYN818 has shown remarkable synergistic effects when used in combination with PARP inhibitors in both in vitro and in vivo studies. It has also demonstrated potent anti-tumor activity, excellent pharmacokinetic properties, and good safety profiles in preclinical studies, with no significant hematological toxicity observed.

Based on preclinical data, SYN818 has the potential to be a "best-in-class" Polθ inhibitor. It not only has the potential to serve as a standalone therapy for HRD cancer cells but can also be used in combination with PARP inhibitors, radiotherapy, and antibody-drug conjugates (ADC) for the treatment of various cancers. It is expected to reduce the clinical toxicity of existing treatment regimens, overcome drug resistance, and holds broad prospects for clinical development.